Active Ingredient
Lidocaine 4%
The following Structured Product Label (SPL) was submitted to the FDA by Aldermed Inc. for the product Lidocaine 4% Patch (NDC 87236-023). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Lidocaine 4%
Topical analgesic
temporarily relieves minor pain.
For external use only
Do not use
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
adults and children over 12 years: clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch (see illustration). Apply sticky side of patch to affected area.
children under 12 years of age: consult a physician.
store in a clean, dry place outside of direct sunlight, protect from excessive moisture.
benzyl alcohol, butylated hydroxyanisole, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, ethylhexylglycerin, glycerin, kaolin, methacrylate copolymer, oleic acid, phenoxyethanol, polyacrylic acid, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, sodium polyacrylate, sorbitol, tartaric acid, titanium dioxide, water
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